QA Specialist III
Core
Ensures manufactured and sterilized units (commercial and clinical) comply with internal procedures prior to release.
Role type
QA Specialist III
Builds
Quality assurance for structural heart medical devices
Domain
Healthcare / Medical Devices / Quality Assurance
Deliverable
product features
Required skills
manufacturing documentation review, discrepancy tracking, SAP transactions, Design History File (DHF) approval, quarantine management, clinical product coordination, auditing
Preferred skills
Associates Degree or college credits
Technologies
SAP
Responsibilities
review manufacturing documentation and lot history, track documentation discrepancies, notify manufacturing personnel of issues, manage quarantine of discrepant materials, release product in SAP, approve Design History Files, audit materials and work
Seniority
Mid-level, hands-on IC
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